[Posted 03/24/2017] AUDIENCE: Risk Manager, Emergency Medicine ISSUE: Phillips is recalling the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing. A delay in delivering therapy could…
Breast Implants: Update – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
[Posted 03/21/2017] AUDIENCE: Plastic Surgery, Oncology, Patient ISSUE: FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data…
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers – FDA Investigating Increased Rate of Major Adverse Cardiac Events
[Posted 03/18/2017] AUDIENCE: Cardiology, Surgery, Risk Manager ISSUE: The FDA is informing health care providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with the approved metallic…
Viberzi (eluxadoline): Drug Safety Communication – Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder
[Posted 03/15/2017] AUDIENCE: Gatroenterology, Patient ISSUE: FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that…
SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall – Failure of Priming Bolus
[Posted 03/14/2017] AUDIENCE: Risk Manager, Patient ISSUE: Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine. During this procedure, patients may…
Duodenoscopes by Fujifilm Medical Systems: Safety Communication – Certain Older Models Removed From Clinical Use
Including Fuji ED-250XL5, ED-250XT5, ED-450XL5 and ED-450XT5 legacy duodenoscope models (250/450 duodenoscope models) [Posted 01/13/2017] AUDIENCE: Gastroenterology, Nursing, Risk Manager ISSUE: Fuji informed the FDA of its plans to remove legacy 250/450 duodenoscope models from clinical use based on the limited number currently in use. The validated manual reprocessing procedures…
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication – UPDATE – Follow Pentax Validated Reprocessing Instructions
[Posted 01/17/2017] AUDIENCE: Risk Manager, Gastroenterology, Surgery, Infectious Disease, Nursing ISSUE: FDA is providing an important update to the February 19, 2016 Safety Communication to inform users about a design issue with the PENTAX ED-3490TK duodenoscope that could increase the risk of patient infection. This safety communication contains updated recommendations…
Vancomycin Hydrochloride for Injection, USP by Hospira: Recall – Particulate Matter in Vial
[Posted 01/25/2017] AUDIENCE: Pharmacy ISSUE: Hospira, Inc. is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. The product is packaged in…
NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Class I Recall – Potential Inaccurate Test Results
[Posted 01/27/2017] AUDIENCE: Laboratory, Patient, Pathology ISSUE: This is a continuation of bioMerieux’s previous recall for NucliSENS easyMAG Magnetic Silica. The firm has identified additional affected product lots, and an additional product, the NucliSENS Magnetic Extraction Reagents, which have been determined to be in scope of the previous recall. bioMerieux…
Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall – Sheath Separation, Kinking, or Tip Damage
[Posted 01/30/2017] AUDIENCE: Risk Manager, Surgery ISSUE: Bard Peripheral Vascular Inc. is recalling the Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the device from the patient’s leg. The company also reports that the sheath may kink, and that its tip…